Inspection of Blood Establishments

GROUP 1 First, we would like express our sincere thanks and appreciation to our friends and colleagues from IBTO for hosting this workshop, hospitality, patience and the very well organized services.

GROUP 1 Sure many thanks to WHO- HQ and WHO-EMR for their continuous support in all aspects of BTS hoping that step by step the blood transfusion we will improve quality and safety of blood and blood products and looking forward at implementing GMP in the our field

1. How to Perform an Inspection of Blood Establishment Preparation for an inspection Conducting an inspection Inspection report Follow up of an inspection

Preparation of an inspection of IBTO and conducting it Preparation of an inspection –Meeting the leading experts and facilitators to learn how to perform inspection –Learn from the IBTO what is there mission, mandate, organization structure, future planes –Decide the departments, date of the inspection (blood donor center, blood components preparation, blood and blood components storage, lab. Testing … etc) 2,3/11/2008 –Select team of inspectors ( 17 inspectors from 9 countries)

2.How We Conducted the Inspection A systematic based inspection based on our knowledge on GMP standards Quality management Personnel and job description Premises and equipment Quality assurance (collection, preparation, testing, storage, release and transportation) Documentation Training Contracts Complaints and recall

During our inspection we realize that the services offered by the IBTO are very extensive and time available is very limited and also the number of inspectors was high enough to be accommodated in the facility. So we decided to reduce the inspection by just over viewing the quality of the services offered by the center in certain departments.

Observation Organization: This is a well organized institution, with a well trained personnel Personnel and job description: The personnel are well trained and adhere to SOPs - GMP

Observation Premises and Equipment: Premises were in accordance with general requirements for BTS Organized Clean Well maintained Relatively systematic flow Adequate premises for duties assigned Equipments: were well maintained, clean and qualified

Observation Donor identification, suitability and acceptance: Standardized donor identification and selection criteria performed by well trained staff according to SOPs and modern software in use Blood/plasma collection:  Separated area  Hiegyne  Clean and maintained equipments  Biosealer  Staff adhering to GMP( SOPs, Universal precautions)

Observation Processing and preparation of blood components, storage: Separated area, clean and well maintained In accordance with SOPs Close system and SCD were in use Facilities for segregate separation of storage area with a system for blood cold chain (temp. recording and monitoring)

Observation Release and transportation: SOPs for: Handling of returned products Handling of reactive product Storage and stock control Documentaion: Software MAK program Back up system Hard copy

Observation Laboratory testing:  Separated area  Clear flow of samples  Cleaning and disinfection (SOPs)  Equipments clean and maintained  Trained staff  Staff adhering to GMP( SOPs, Universal precautions)

3. Lesson learned &needs identified in the region 1.IBTO provides the best practice model in the region by having: - Organization and centralized services were it is needed -100% VNRBD -Gov. and staff commitment - Contract for plasma fractionation 2.Iran experience of contract for plasma fractionation give the region the opportunity to think seriously and plan for establishing a plasma manufacturing plant in the region

However we need to strengthen the existing national blood programs by reviewing all aspects of GMP with the goal of assuring the quality and safety of our blood supply. Strength: Commitment from gov. Infrastructure Paid donation stopped Organization

weakness Organization NRA Collection- VNRBD Software data base Training and training facilities However we realize that this a long term process

Needs Accordingly, we need to look at: 1.Centralization of the services were it is needed 2.Review and Promote existing GMP standards to in accordance with WHO guidelines 3.Establish NRA and train inspectors in the blood establishments to enforce adherence to international GMP standards in the region 4.To promote the sharing of experience and cooperation regionally and globally in GMP in blood establishments

Needs 5. Establish same ethical standards in GMP guidelines for all kinds in blood establishments 6. Software data base and country BTS network 7. Training of staff and promoting the training of expertise in GMP 8. Afganistan needs more support in the field of BTS

T HANKS VERY MUCH TO IBTO THANKS FOR WHO THANKS FOR ALL